Kornimate/medical-research-clean huggingface dataset:
national active surveillance network and pharmacogenomics of adverse drug reactions in children

Conditions: Adverse Drug Reaction (ADR)

Summary: the purpose of the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions and children and adults who take drugs and do not experience any adverse drug effects; (2) to determine if genetic differences between the two groups contribute to causing the adverse drug reactions; and (3) to develop patient specific drug dosing guidelines to prevent future adverse drug reactions. we also wish to compare the use of prescription drugs, medical and hospital services and vital statistics between bc participants who experience adverse drug reactions and those who do not. study hypothesis: genetic differences may contribute to patients' response to drugs and may be responsible for adverse drug reactions.

cpnds will identify adr predictive markers by comparing dna and plasma samples from patients that suffer adrs with samples from control populations that are stratified by medication type and age. the gatc will obtain its clinical material for adr patients mainly, from hospital-based active surveillance network across canada's major hospitals. 1. cpnds will examine known snps in candidate genes related to the adr (i.e. drug metabolism genes, drug transporter genes, drug target genes, and other disease-specific genes or genes related to the physiological pathway of the adr.) 2. cpnds will discover novel adr predictive snps and mutations by sequencing dna samples from our patient cohorts. cpnds will also genotype and sequence dna samples from populations of controls that received the same drugs, but did not suffer adrs; and a second population of control patients who represent a random sample of the population of known ethnic backgrounds. novel adr predictive snps and mutations will be functionally validated by pharmacokinetic approaches applied to time course analysis of drug concentrations for each specific genotype. pharmacokinetic studies will also be used to determine the drug concentration in patients to characterize possible mechanisms of the adr, translating into rational approaches to the choice of candidate genes to be examined in the genomic analyses. the cost-effectiveness of an adr screening program for the prevention of adrs in children and adults will be calculated in detailed health-economic studies.

Eligibility criteria:
inclusion criteria: * children under 19 years who have taken drugs. * biological parents of children who have had an adr. * patients/parents who speak and understand english (except in quebec). * adults (for validation of findings in children)

Keywords: observational controlled study genomic biomarkers adverse drug reaction in children or adults
product evaluation of a newly developed intermittent catheter.

Conditions: Incontinence, Urinary

Summary: the aim of the study is to investigate the navigation of a newly developed catheter.


Eligibility criteria:
inclusion criteria: 1. male and at least 18 years 2. has used intermittent self-catheterization at least 3 months 3. has normal to slightly reduced hand mobility 4. use catheter size ch12 or ch14 (must use same size during product evaluation) exclusion criteria: 1. currently receiving treatment for urinary tract infection 2. currently receiving chemotherapy
can probiotic vivomixx eradicate colonization with esbl?

Conditions: Antibiotic Resistant Infection

Summary: can probiotic vivomixx eradicate extended spectrum betalactam (esbl) colonization in adult patients?

infections due to extended spectrum cephalosporin-resistant enterobacteriaceae (escre) are a widely recognized public health threat. the prevalence of escre is comparably low in sweden but is steadily increasing; approximately 5 % of swedish inhabitants are carrying escre in the gut. escre can lead to infections mainly from urine, abdomen and blood. these infections can be problematic to treat with current available antibiotics and represent a clinical challenge for clinicians around the world with considerable mortality and morbidity. risk factors for acquiring an escre is e.g. antibiotic treatment, trips to high prevalence countries, family member with escre etc. the duration of escre carriage is not known. one swedish study showed that escre carriage can continue despite antibiotic treatment and that false negative cultures in between positive cultures are common. since few new groups of antibiotics have been developed in the last decades, infections due to escre may be increasingly difficult to treat. the possibility of escre decolonization is therefore a desirable aim, in particular the more virulent enterobacteriaceae strains leading to recurrent clinical infection episodes. probiotics are microorganisms marketed as useful bacteria effective locally in the gut. in recent years many studies have focused on potential health benefits in a range of different gastrointestinal diseases e.g. ulcerous colitis, crohn's disease, antibiotic associated diarrhoea where probiotics potentially have a therapeutic role4. smaller studies have shown that probiotics possibly can bind and eliminate enteric pathogenic bacteria5-6. a small in vitro study showed that probiotics can be effective against antibiotic resistant bacteria. larger clinical treatment studies are needed. escre constitutes a clinical problem and is largely seen in escherichia coli and klebsiella spp. the investigator's theory is that the probiotic vivomixx can reject escre and thus decolonize the gut. vivomixx contains eight different strains of probiotics; bifidobacterium breve, b. longum, b. infantis, lactobacillus acidophilus, l. plantarum, l. paracasei, l. bulgaricus, streptococcus thermophilus and has the best documentation in clinical studies for enteric diseases of today.

Eligibility criteria:
inclusion criteria: * chronic (more than three months) esbl colonization of the same strain as determined by * species, phenotype and antibiogram. * patients must be able to swallow sachets. * must be able to speak and understand swedish. * must have a permanent residence in sweden. * must be able to sign informed consent in swedish. exclusion criteria: * immunosuppression (i.e. chemotheraphy, treatment with tnf-alpha-inhibitors). * in patient care. * immunodeficiency * psychiatric disorder * alcohol or substance abuse * dementia * invasive catheters.
efficacy and safety of faster-acting insulin aspart compared to novorapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted globally. the aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to novorapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.


Eligibility criteria:
inclusion criteria: - male or female, 1 year above or equal to age below 18 years at the time of signing informed consent and below 18 years at the time of randomisation - diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) - ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or neutral protamine hagedorn (nph) insulin for at least 90 days prior to the screening visit - hba1c (glycosylated haemoglobin) below or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit exclusion criteria: - more than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit - treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
effects of a dance and walking program for people with parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd), characterized as progressive and neurodegenerative, is one of the most frequent neurological diseases of the present time. patients with pd present motor impairment, such as muscle stiffness, rest tremor, slow movements, postural instability, and gait and balance alterations; and non-motor factors, such as cognitive and neuropsychiatric disorders, depressive symptoms, and a consequent decrease in quality of life (ql). dance can be an important tool for the complementary treatment of these patients, when added to traditional drug therapies and physiotherapies. thus, the present study aims to verify the effects of a program of dance and walking in gait and ql of 38 adults with pd, divided in two groups, and to compare the aspects of functionality, dynamic stability, kinematics and ql. the data collection instruments will be a personal data sheet of the patients, the hoehn and yahr scale (h\&y), the rehabilitation index (ri), the motor part of the unified pd rating scale (updrs iii), the timed up ang go test (tug), the kinematic analysis of walking and the parkinson's disease questionnaire (pdq-39). statistical package for social sciences (spss) software version 20.0 will be used to analyze the data, using the wilcoxon test for non-parametric data and the paired t-test for parametric data, in order to compare pre and post intervention data. the significance level adopted for both tests will be p \<0.05. it is expected that a program of 24 sessions of dance classes will be as or more effective than a program of 24 walking sessions for the gait quality and ql for the participants of the study.


Eligibility criteria:
inclusion criteria: * both sex; * equal to or more than 50 years old; * parkinson disease in regular medical treatment and follow-up; * illness diagnosis equal to or more than one year; * h\&y scale between one and three; * able to walk independently or with a walking stick. exclusion criteria: * more than six absences in dance class or in the walking training (25%); * start a new activity parallel to the project; * risk factors: recent surgeries, deep brain stimulation surgery (dbs), other associated neurological diseases or other chronic diseases.

Keywords: parkinsonian disorders dance therapy rehabilitation kinematics locomotion quality of life
intubation during pediatric resuscitation

Conditions: Cardiac Arrest; Endotracheal Intubation; Pediatric Manikin

Summary: the european resuscitation council (erc) 2010 cardiopulmonary resuscitation (cpr) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. we examine the performance of the berci-kaplan dci (berci), the glidescope (gvl), the airtraq, the pentax aws (pentax) and the miller laryngoscope (mil) for endotracheal intubation (eti) during pediatric resuscitation with and without chest compressions.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * minimum 1 year of work experience in emergency medicine * experienced emergency medicine personnel (physicians, nurses, paramedics) exclusion criteria: * not meet the above criteria * wrist or low back diseases
avoid ffs - use of the atrial pacemaker lead 1699 with very short tip ring spacing to avoid far field sensing

Conditions: Atrial Fibrillation; Bradycardia

Summary: the purpose of this study is to evaluate the possibility to program the shortest possible post ventricular atrial blanking period (pvab) and high sensitivity without getting inappropriate mode switch due to far field r-wave sensing when using the new tendril 1699t lead. comparison with tendril 1688t or 1388t with optimized post ventricular atrial blanking (pvab).

far-field r-wave sensing (ffs) in the atrial channel of dual chamber pacemakers is a relevant source for inappropriate mode switch from the ddd mode to the ddi or vdi mode. inappropriate loss of atrioventricular synchrony due to false positive mode switch is hemodynamically disadvantageous, may induce atrial tachyarrhythmias, can lead to pacemaker syndrome, and impairs the reliability of pacemaker holter data. the aim of the study is to determine whether the use of a new atrial screw in lead with ultra short tip-ring distance of 1.1 mm (study group) eliminates the need for individual adjustment of the postventricular atrial blanking period (pvab) based on an additional test in the control group with standard leads.

Eligibility criteria:
inclusion criteria: * indication for dual chamber pacing * implantation of an identity (adx) dr or victory or later pacemaker (st. jude medical) * bipolar atrial pacing electrode * age \>= 18 years exclusion criteria: * persistent / permanent atrial arrhythmia * pacemaker revision * pregnancy * participation in another study involving active implantable medical devices * unable to complete follow up * missing patient informed consent * cardiac surgery or myocardial infarction within the last 4 weeks * planned cardiac surgery within 3 months after enrollment

Keywords: farfield sensing pacing lead postventricular atrial blanking bradycardia
serum lipid profile and lip squamous cell carcinoma

Conditions: Lipid Profile; Lipids; SCC - Squamous Cell Carcinoma; Lip Cancer; Oral Cancer

Summary: the goal of this observational retrospective study is to assess whether serum lipid levels differ between patients diagnosed with lip squamous cell carcinoma (scc) and healthy individuals. the study aims to evaluate if alterations in lipid parameters, especially ldl levels, are associated with the presence of lip scc and could serve as potential early biomarkers. the main research questions are: do patients with lip scc show significantly lower ldl levels compared to healthy controls? are there significant differences in total cholesterol (tc), triglycerides (tg), hdl, and vldl between the two groups? a retrospective analysis was conducted using existing medical records of patients with lip scc and healthy subjects obtained from 2018-2023.

demographic data and lipid profile information were collected from 56 patients (28 lip scc and 28 healthy). the lipid parameters included were total cholesterol (tc), triglycerides (tg), high density lipoprotein (hdl), low density lipoprotein (ldl) and very low-density lipoprotein (vldl).

Eligibility criteria:
inclusion criteria: * patients clinically evident and histopathologically confirmed with lip scc (study group) * subjects without any underlying systemic disease (control group) exclusion criteria: * age younger than 18 years * pregnancy * smoking * history of radiotherapy or chemotherapy * family history of hyperlipidemia * accompanying malignancies other than lip scc for both study and control groups

Keywords: oral cancer lipids lipid levels non-smokers lip squamous cell carcinoma
improvement of tinnitus after oral zinc on patients with noise-induced hearing loss

Conditions: Hearing Loss, Noise-Induced; Tinnitus, Noise Induced; Zinc Deficiency

Summary: twenty patients with tinnitus and a typical noise-induced hearing loss (nihl) audiogram were included. each subject underwent an otoscopic examination, distortion product otoacoustic emissions, tinnitus-match testing, tinnitus handicap inventory (thi) and serum zinc level analyses. after 2 months of treatment with zinc, all tests were repeated.

this study enrolled patients who visited our out-patient department with the primary complaint of tinnitus. a full medical history assessment was performed, and each patient underwent an otoscopic examination, a basic audiologic evaluation. we selected the patients whose audiogram data met the inclusion criteria for nihl: 1) bilateral typical nihl audiogram and type a tympanogram; 2) hearing threshold above 4 kilohertz (khz) was greater than 25 db hearing level (hl); 3) audiogram showed the characteristic 4 khz or 6 khz notch (average hearing threshold was 10 db hl higher than the baseline); 4) up-turn phenomenon appeared above 6 khz or 8 khz, and 5) symmetrical hearing loss threshold over bilateral ears and the disparity was less than 10 db hl. patients with other otologic diseases were excluded. a full medical history assessment was performed, and each patient completed the nihl questionnaire (supplementary s1), audiogram, tympanogram, speech discrimination test, distortion product otoacoustic emissions (dpoae) testing, pitch and loudness match of the tinnitus, tinnitus handicap inventory (thi) and serum zinc level analyses. all tests were repeated after 2 months of treatment with zinc gluconate (zinga 78 mg, 10 mg elemental zinc), two tablets twice per day (40 mg per day).

Eligibility criteria:
inclusion criteria: * 1) bilateral typical nihl audiogram and type a tympanogram; 2) hearing threshold above 4k hz was greater than 25 db hl; 3) audiogram showed the characteristic 4 khz or 6 khz notch (average hearing threshold was 10 db hl higher than the baseline); 4) up-turn phenomenon appeared above 6 khz or 8 khz, and 5) symmetrical hearing loss threshold over bilateral ears and the disparity was less than 10 db hl. patients with other otologic diseases were excluded. exclusion criteria: * patients with pregnancy, psychologic diseases and other otologic diseases were excluded.
drug-drug interaction study between edp-235, midazolam, caffeine and rosuvastatin in healthy subjects

Conditions: COVID-19

Summary: a drug-drug interaction study to assess the effects of edp-235 on the pharmacokinetics and safety of midazolam, caffeine and rosuvastatin.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject * healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive * screening body mass index (bmi) of 18 to 30 kg/m2 with a minimum body weight of 50 kg * female subjects of childbearing potential must agree to use two effective methods of contraception from the date of screening until 90 days after the last dose of edp-235. a male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of screening to 90 days after his last dose of study drug. exclusion criteria: * clinically relevant evidence or history of illness or disease * pregnant or nursing females * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection * a positive urine drug screen at screening or day -1 * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy) * history of regular alcohol consumption * participation in a clinical trial within 30 days prior to the first dose of study drug * history of drug allergy to midazolam, caffeine, or rosuvastatin

Keywords: drug-drug interaction
merging yoga and group ot (my-ot) to improve balance and decrease fall risk after stroke

Conditions: Stroke

Summary: the long-term goal of this project is to advance best practices in occupational therapy (ot) to manage fall risk factors and reduce fall rates in older adults with stroke. to address this long-term goal, this team previously developed and pilot-tested a therapeutic yoga intervention to improve balance, balance self-efficacy, and fear of falling and a group ot intervention to improve the management of fall risk factors and fear of falling. the success of both prior studies supports merging yoga and group ot to improve balance, balance self-efficacy, and fall risk factor management. the objectives of this feasibility study are to 1) further develop, standardize, and manualize the my-ot intervention and 2) assess change in balance, balance self-efficacy, and fall risk factor management.

8 week intervention of yoga plus occupational therapy. the objectives of this feasibility study are to 1) further develop, standardize, and manualize the my-ot intervention and 2) assess change in balance, balance self-efficacy, and fall risk factor management.

Eligibility criteria:
inclusion criteria: * stroke \>6 months prior * 59 years or older * prior fall or fear of falling (fof) * completed all stroke rehabilitation * able to stand with or without an assistive device * impaired balance with a score of \<46 on the berg balance scale * able to speak english * score \>4 out of 6 on the short mini mental status exam (callahan, unverzagt et al., 2002) * able and willing to attend twice weekly sessions for 8 weeks. exclusion criteria: * people with life expectancy \<9 months; * inability to attend sessions due to unresolved transportation issues; * inability or refusal to provide informed consent

Keywords: yoga occupational therapy stroke
ciprofloxacin biothrax co-administration study

Conditions: Anthrax

Summary: the purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of biothrax® (anthrax vaccine adsorbed or ava). this study will be conducted in the united states (us) in 154 healthy male and female volunteer subjects ages 18 to 45. the duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)

biothrax is the only fda-licensed vaccine for the prevention of anthrax infection. this is a randomized, open-label, phase 2, multi-center trial to investigate the potential interactions of ciprofloxacin and biothrax.

Eligibility criteria:
inclusion criteria: * be between 18 and 45 years of age, at the time of enrollment * be in good health as determined by the investigator from medical history and a physical examination. * if a pre-menopausal female, must be using acceptable methods of birth control. * be willing and able to return for all follow-up visits and blood and urine collections for the duration of the trial * be willing and able to complete a web-enabled electronic diary and report concomitant medications, adverse events, and biothrax reactogenicity events during the trial * be able to understand and communicate in english. exclusion criteria: * prior immunization with anthrax vaccine or known exposure to anthrax organisms * intend to enlist in the military during the study. * have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex. * plan to receive experimental products 30 days prior to study entry or at any time during the study * have received a live vaccine in the 30 days before study entry * plan to receive a live vaccine at any time during the study. * have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates * have received immunosuppressive therapy (including systemic steroids) within 30 days prior to trial entry * have any other condition known to produce or be associated with immunosuppression * have received cytotoxic therapy in the previous 5 years * a chronic condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with trial evaluations or completion of the study.

Keywords: post-exposure prophylaxis toxin neutralization assay